The new ISO 22000

Dr. David Rosenblatt

Sher Consulting and Training
Major changes compared to
ISO 22000:2005
High Level Structure (HLS) alignment
Animal food and feed included in scope
Significant Food Safety Hazard 2005
Significant Food Safety Hazard 2005
biological, chemical or physical agent in
food, or condition of food, with the
potential to cause an adverse health effect
Significant Food Safety Hazard 2018
biological, chemical or physical agent in
food, or condition of food, with the
potential to cause an adverse health effect
Significant Food Safety Hazard 2018
Significant Food Safety Hazard 2018
food safety hazard, identified through the
hazard assessment, which needs to be
controlled by control measures
Control Measure 2005
Control Measure 2005
action or activity that can be used to
prevent or eliminate a food safety hazard or
reduce it to an acceptable level
Control Measure 2018
is essential
action or activity that can be used to
prevent or eliminate a food safety hazard or
reduce it to an acceptable level
Critical Control Point (CCP) 2005
Critical Control Point (CCP) 2005
step at which control can be applied
and is essential to prevent or eliminate a
food safety hazard or reduce it to an
acceptable level
Critical Control Point (CCP) 2018
a control measure is
step at which control can be applied
and is essential to prevent or eliminate a
food safety hazard or reduce it to an
acceptable level, and defined critical limits
and measurement enable the application of
corrections
Operational PRP (oPRP) 2005
Operational PRP (oPRP) 2005
PRP identified by the hazard analysis as
essential in order to control the likelihood
of introducing food safety hazards to
and/or the contamination or proliferation of
food safety hazards in the product or in the
processing environment
Operational PRP (oPRP) 2018
PRP identified by the hazard analysis as
essential in order to control the likelihood
of introducing food safety hazards to
and/or the contamination or proliferation of
food safety hazards in the product or in the
processing environment
Operational PRP 2018
CM or combination of CMs applied to
prevent or reduce a significant food safety
hazard to an acceptable level, and where
action criterion and measurement or
observation enable effective control of the
process and/or product
Action Criterion 2018
Action Criterion 2018
measurable or observable specification for the
monitoring of an oPRP
Action Criterion 2018
measurable or observable specification for the
monitoring of an oPRP
Note: an AC is established to determine whether an oPRP
remains in control, and distinguishes between what is
acceptable (criterion met or achieved means the oPRP is
operating as intended) and unacceptable (criterion not
met nor achieved means the oPRP is not operating as
intended).
 CCP oPRP
2018
Control measure or
Step in the process
combination of CMs

Critical limits Action criteria

Measurement or
Measurement
observation
Control of product or
Control of product
process
 CCP oPRP
2018
Control measure or
Step in the process
combination of CMs

Critical limits Action criteria

Measurement or
Measurement
observation
Control of product or
Control of product
process
 CCP oPRP
2018
Control measure or
Step in the process
combination of CMs

Critical limits Action criteria

Measurement or
Measurement
observation
Control of product or
Control of product
process
 CCP oPRP
2018
Control measure or
Step in the process
combination of CMs

Critical limits Action criteria

Measurement or
Measurement
observation
Control of product or
Control of product
process
 CCP oPRP
2018
Control measure or
Step in the process
combination of CMs

Critical limits Action criteria

Measurement or
Measurement
observation
Enable control of
Enable correction
product or process
8.2 PRPs
8.2 PRPs
8.2.3 When selecting and/or establishing PRP(s),
the organization shall ensure that applicable
statutory, regulatory and mutually agreed
customer requirements are identified.
8.2 PRPs
8.2.3 When selecting and/or establishing PRP(s),
the organization shall ensure that applicable
statutory, regulatory and mutually agreed
customer requirements are identified. The
organization should consider:
a) the applicable part of the ISO/TS 22002 series;
8.2 PRPs 1. Food manufacturing

2. Catering

3. Farming

4. Food packaging

6. Feed
8.5 Hazard control
8.5.1 Preliminary steps to enable hazard analysis
8.5 Hazard control
8.5.1 Preliminary steps to enable hazard analysis
8.5.1.2 The organization shall maintain documented
information concerning all raw materials, ingredients and
product contact materials to the extent needed to
conduct the hazard analysis, including the following, as
appropriate:
8.5 Hazard control
8.5.2 Hazard analysis
8.5.2.2 Hazard identification
8.5 Hazard control
8.5.2 Hazard analysis
8.5.2.2 Hazard identification
8.5.2.2.1 The organization shall identify and document
all food safety hazards that are reasonably expected
to occur in relation to the type of product, type of
process and process environment.
8.5 Hazard control
8.5.2 Hazard analysis
8.5.2.2 Hazard identification

Hazards should be considered in sufficient

detail to enable hazard assessment and the
selection of appropriate control measures.
 8.5.2.2 Hazard identification
2005
Pathogens
 8.5.2.2 Hazard identification
2005 2018
Pathogens Introduction of pathogenic organisms resulting from human hand
contact:
 8.5.2.2 Hazard identification
2005 2018
Pathogens Introduction of pathogenic organisms resulting from human hand
contact:
Fecal viruses: Hepatitis A/E virus, Norovirus and noro-like viruses
 8.5.2.2 Hazard identification
2005 2018
Pathogens Introduction of pathogenic organisms resulting from human hand
contact:
Fecal viruses: Hepatitis A/E virus, Norovirus and noro-like viruses
Fecal bacteria: Shigella, Salmonella, L. monocytogenes, E. Coli STEC
 8.5.2.2 Hazard identification
2005 2018
Pathogens Introduction of pathogenic organisms resulting from human hand
contact:
Fecal viruses: Hepatitis A/E virus, Norovirus and noro-like viruses
Fecal bacteria: Shigella, Salmonella, L. monocytogenes, E. Coli STEC
Fecal worms: A. lumbricoides
 8.5.2.2 Hazard identification
2005 2018
Pathogens Introduction of pathogenic organisms resulting from human hand
contact:
Fecal viruses: Hepatitis A/E virus, Norovirus and noro-like viruses
Fecal bacteria: Shigella, Salmonella, L. monocytogenes, E. Coli STEC
Fecal worms: A. lumbricoides
Protozoic fecal parasites: C. parvum, E. hystolitica, C. cayatenensis
 8.5.2.2 Hazard identification
2005 2018
Pathogens Introduction of pathogenic organisms resulting from human hand
contact:
Fecal viruses: Hepatitis A/E virus, Norovirus and noro-like viruses
Fecal bacteria: Shigella, Salmonella, L. monocytogenes, E. Coli STEC
Fecal worms: A. lumbricoides
Protozoic fecal parasites: C. parvum, E. hystolitica, C. cayatenensis
Staphylococcus aureus
8.5.2.3 Hazard assessment
 8.5.2.3 Hazard assessment
The organization shall evaluate each food safety
hazard with regard to:
 8.5.2.3 Hazard assessment
2005
the possible
severity of adverse
health effects and
the likelihood of
their occurrence
 8.5.2.3 Hazard assessment
2005 2018
the possible a) the likelihood of its occurrence
severity of adverse in the end product prior to
health effects and application of control measures;
the likelihood of b) the severity of its adverse
their occurrence health effects in relation to the
intended use
8.5 Hazard control
8.5.4 Hazard control
plan (HACCP/oPRP plan)
8.5 Hazard control
22000:
8.5.4 Hazard control 7.6 2005

plan (HACCP/oPRP plan) CCPs

7.5
oPRPs

HCP
8.5 Hazard control
8.5.4.2 Critical limits and action criteria
8.5 Hazard control
8.5.4.2 Critical limits and action criteria
CCP oPRP
Conformance with critical
limits shall ensure that the
acceptable level is not
exceeded.
8.5 Hazard control
8.5.4.2 Critical limits and action criteria
CCP oPRP
Conformance with critical Conformance with action
limits shall ensure that the criteria shall contribute to
acceptable level is not the assurance that the
exceeded. acceptable level is not
exceeded.
8.5 Hazard control
8.5.4.3 Monitoring systems:
8.5 Hazard control
8.5.4.3 Monitoring systems:
the monitoring method and frequency shall be
CCP oPRP
capable of timely detection of
any failure to remain within
critical limits, to allow timely
isolation and evaluation of the
product
8.5 Hazard control
8.5.4.3 Monitoring systems:
the monitoring method and frequency shall be
CCP oPRP
capable of timely detection of proportionate to the likelihood
any failure to remain within of failure and the severity of
critical limits, to allow timely consequences.
isolation and evaluation of the
product
8.7 Control of monitoring and measuring
8.7 Control of monitoring and measuring
When the equipment or process environment is
found not to conform to requirements, the
organization shall assess the validity of the
previous measurement results…
8.7 Control of monitoring and measuring
The organization shall take appropriate action in
relation to the equipment or process
environment and any product affected by the
non-conformance.
8.7 Control of monitoring and measuring
Interpretation: devices used to monitor CCPs and
oPRPs should be verified for accuracy at least
daily!
8.9 Control of nonconformities
8.9 Control of nonconformities
CCP oPRP
When critical
limits at CCPs are
not met, affected
products shall be
identified and
handled as
potentially
unsafe products
8.9 Control of nonconformities
CCP oPRP
When critical Where action criteria for an OPRP are not
limits at CCPs are met, the following shall be carried out:
not met, affected a) determination of the consequences of that
products shall be failure;
identified and b) determination of the cause(s) of failure;
handled as c) identification of the affected products and
potentially handling in accordance with 8.9.4 (Handling
unsafe products of potentially unsafe products).
8.9 Control of nonconformities
8.9.4 Handling of potentially unsafe products
8.9 Control of nonconformities
8.9.4 Handling of potentially unsafe products
CCP oPRP
Products affected by failure
to remain within critical
limits at CCPs shall not be
released, but shall be
handled in accordance with
8.9.4.3 (Disposition of
nonconforming products).
8.9 Control of nonconformities
8.9.4 Handling of potentially unsafe products
CCP oPRP
Products affected by failure Products affected by failure to
to remain within critical meet action criterion for OPRPs
limits at CCPs shall not be shall only be released as safe
released, but shall be when any of the following
handled in accordance with conditions apply:
8.9.4.3 (Disposition of
nonconforming products).
8.9 Control of nonconformities
8.9.4 Handling of potentially unsafe products
a) evidence other than the monitoring system
demonstrates that the control measures have been
effective;
8.9 Control of nonconformities
8.9.4 Handling of potentially unsafe products
b) evidence shows that the combined effect of the
control measures for that particular product conforms
to the performance intended (i.e. identified
acceptable levels);
8.9 Control of nonconformities
8.9.4 Handling of potentially unsafe products
c) the results of sampling, analysis and/or other
verification activities demonstrate that the affected
products conform to the identified acceptable levels
for the food safety hazard(s) concerned.